PARTNER II trial of Sapien XT meets endpoint in aortic stenosis patients- Edwards Lifesciences

Edwards Lifesciences announced that the randomized PARTNER II Trial comparing the SAPIEN XT valve to surgery in intermediate-risk patients successfully achieved its primary endpoint at two years. The PARTNER II Trial is the first randomized clinical trial comparing outcomes of severe, symptomatic aortic stenosis patients who were at intermediate risk for open-heart surgery. The composite primary endpoint of the trial was all-cause mortality or disabling stroke at two years. The event rate was 19.3 percent for transcatheter aortic valve replacement (TAVR) with the SAPIEN XT valve, which was non-inferior, compared with 21.1 percent for surgery.

For the 76 percent of SAPIEN XT patients receiving the transfemoral approach, the as-treated event rate was 16.3 percent, which was superior to surgery. The results of the study were presented as part of the late-breaking clinical trials at the American College of Cardiology's 65th Annual Scientific Session, and simultaneously published online in The New England Journal of Medicine.

Comment: The SAPIEN XT valve and, more recently, the SAPIEN 3 valve, are approved in the United States for the treatment of high-risk patients with severe, symptomatic aortic stenosis; the valves are not approved for the treatment of intermediate-risk patients. The SAPIEN family of valves has been used in the treatment of more than 150,000 patients globally.